Nalbuphine

Opioid analgesics are core medications for the management of moderate to severe pain, but traditional μ-receptor agonists are often accompanied by clinical pain points such as respiratory depression and high risk of addiction. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine exerts central analgesic effect by agonizing κ-receptors, while partially antagonizing μ-receptors. On the premise that its analgesic potency is equivalent to that of morphine, it has a lower incidence of respiratory depression and lower risk of addiction. It is clinically mainly used for moderate to severe postoperative pain, cancer pain and obstetric labor analgesia, and its applicable population covers adult and pediatric patients. It has become one of the preferred drugs in multimodal analgesia regimens.At present, the global nalbuphine market size is approximately USD 1.2 billion, with a compound annual growth rate maintained at around 7.2%. The growth momentum mainly comes from the increase in surgical volume and the popularization of standardized treatment for cancer pain. The Chinese market is the fastest growing region. In 2023, its market size exceeded RMB 2.7 billion, with a compound growth rate of more than 18% in the past five years. In terms of competitive landscape, the domestic preparation market is dominated by generic drugs, and no original research product has been launched yet. The supply of active pharmaceutical ingredients was long dependent on imports previously. With the gradual maturity of synthesis processes of domestic enterprises, the process of domestic substitution is accelerating.The original research enterprise of nalbuphine is Wellcome UK (later merged into GlaxoSmithKline), and the original research brand name is Nubain. Its core compound patent in the United States expired in 1988, and there is no original research compound patent protection in China. The main dosage form of the original research product is injection, with specifications including 10mg/ml and 20mg/2ml, which has been included in the FDA Orange Book Reference Listed Drug Catalog. No original research preparation has been approved for marketing in the domestic market. Up to now, the nalbuphine APIs of 12 domestic enterprises have obtained Class A status through CDE registration, and the nalbuphine injections of another 7 enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)CATO provides a full set of impurity reference standards for nalbuphine API, which can fully cover the research needs of intermediates, by-products and degradation impurities in the synthesis process. The products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities are in stock, and spot orders placed before 16:00 can be dispatched on the same day, which can efficiently support the whole process of pharmaceutical enterprises' API R&D, quality research and registration declaration.

目前全球纳布啡市场规模约12亿美元，年复合增长率维持在7.2%左右，增长动力主要来自外科手术量提升及癌痛规范化治疗的普及。中国市场是增速最快的区域，2023年市场规模突破27亿元人民币，近五年复合增长率超18%。竞争格局方面，国内制剂市场以仿制药为主，暂无原研产品上市，原料药供应此前长期依赖进口，随着国内企业合成工艺逐步成熟，国产化替代进程正在加快。

纳布啡原研企业为英国威康（后并入葛兰素史克），原研商品名为Nubain，美国核心化合物专利于1988年到期，中国区域无原研化合物专利保护。原研主要剂型为注射液，规格包括10mg/ml、20mg/2ml，已列入FDA橙皮书参比制剂目录。国内市场暂无原研制剂获批上市，截至目前已有12家国内企业的纳布啡原料药通过CDE登记获得A状态，另有7家企业的纳布啡注射液获批上市。（数据截至2025年6月，最新请以CDE官网为准）

CATO/佳途科技提供纳布啡API全套杂质标准品，可全面覆盖合成过程中间体、副产物及降解杂质研究需求，产品符合中国药典、FDA等多法规体系合规要求，大部分杂质备有现货，16:00前下单的现货订单可当日发出，能够高效支持药企的原料药研发、质量研究及注册申报全流程工作。